Clearwater, FL — FDA Alert: Glucose Monitors Recalled for False Readings

Clearwater, FL (December 3rd, 2025) – The U.S. Food and Drug Administration (FDA) has issued an urgent safety alert for certain FreeStyle Libre glucose monitoring sensors. The recall of these medical devices came after the manufacturer, Abbott Diabetes Care, disclosed seven deaths and 736 severe injuries connected to the faulty sensors. These devices, relied on by thousands of people in Florida and through the U.S. who are managing diabetes, have been displaying dangerously inaccurate blood sugar readings that can trigger life-threatening treatment errors.

For Clearwater families affected by these defective glucose monitors, understanding your legal rights is essential. Product manufacturers bear a legal responsibility to ensure their medical devices function safely for consumer use. When that responsibility is violated and people suffer harm, victims may be entitled to compensation through product liability claims. 

To discuss your rights and next steps, contact Light & Wyatt Law Group at 727-499-9900. We offer free consultations.

Which FreeStyle Libre Models Are Affected by the Recall?

The affected products include certain FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor models. Abbott sent notification letters to customers, but many Clearwater residents may still be using these dangerous devices without realizing the risks. A full list of the affected models is available on the FDA’s website. 

The FreeStyle Libre continuous glucose monitor system enables diabetes patients to track their blood sugar levels without conventional finger-stick tests. However, these specific sensor models have been showing false low glucose measurements, creating a serious health concerns for diabetic patients who rely on accurate readings to manage their condition safely.

Why Are Defective Glucose Monitors Dangerous for Diabetes Patients?

When a diabetic patient receives inaccurate data indicating their blood sugar is excessively low, they may consume unnecessary carbohydrates or omit insulin doses based on that erroneous information. These mistaken treatment responses create severe medical dangers that can escalate quickly.

Patients who omit insulin or eat or drink unneeded carbohydrates based on false data may experience dangerously elevated blood sugar levels, triggering diabetic ketoacidosis, acute hyperglycemia, or other life-threatening complications. The FDA’s report confirms this defect has already resulted in hundreds of severe injuries and seven confirmed fatalities, demonstrating the life-or-death stakes when glucose monitoring devices malfunction.

Understanding these complications is critical. Diabetic ketoacidosis occurs when the body lacks sufficient insulin and begins breaking down fat for energy, producing dangerous acids called ketones that accumulate in the bloodstream. Symptoms can develop within 24 hours and include excessive thirst, frequent urination, nausea and vomiting, abdominal pain, weakness, rapid breathing, fruity-smelling breath, and confusion. Without immediate medical treatment, DKA can lead to severe dehydration, brain swelling, loss of consciousness, coma, or death.

Acute hyperglycemia from skipped insulin doses can cause similar dangers, including severe dehydration, electrolyte imbalances, impaired organ function, and increased risk of heart attack or stroke. These complications are particularly dangerous for elderly patients, individuals with other health conditions, and those who live alone and may not recognize warning signs in time to seek emergency care.

Product Liability Law and Defective Medical Devices

Under Florida product liability law, manufacturers can be held legally accountable when defective products cause injury or death. Three primary categories of defects can establish the foundation of a product liability claim: design defects, manufacturing defects, and inadequate warnings.

In cases involving the FreeStyle Libre sensors, patients may have grounds for claims based on design defects if the fundamental sensor technology was flawed from inception, manufacturing defects if particular batches were improperly produced, or inadequate warnings if Abbott knew about the problem but didn’t properly notify users or issue timely recalls.

Florida law permits injured parties to seek compensation for medical expenses, lost wages, pain and suffering, and in cases involving death, wrongful death damages for surviving family members. When a defective medical device like a glucose monitor causes harm, victims don’t need to prove the manufacturer was negligent. Rather, they need only show that the product was defective and caused their injuries. 

Product liability cases involving medical devices are complex. They require thorough investigation, expert testimony, and detailed documentation of how the defect caused specific harm. However, these cases are crucial for holding manufacturers accountable and preventing future injuries to other consumers.

Frequently Asked Questions

What should I do if I experienced health problems while using a FreeStyle Libre sensor?

Stop using the device immediately and verify if your sensor model is affected by checking Abbott’s website. Seek medical attention for any health complications and inform your doctor about the defective device. Document all medical treatments, keep the defective sensor if possible, and consult with a defective product lawyer to discuss your legal options. Time limits apply to product liability claims, so prompt action is important.

Can I file a claim if my loved one died from complications related to the defective glucose monitor?

Yes, family members may pursue wrongful death claims when defective products cause fatal injuries. Florida law allows certain family members to seek compensation for funeral expenses, medical bills, loss of financial support, and loss of companionship. An experienced product liability attorney can evaluate your specific situation and explain your legal rights during a free consultation.

How long do I have to file a product liability claim in Florida ?

Florida’s statute of limitations for product liability cases is generally two years from the date of injury or discovery of the defect. However, exceptions and complications can affect this deadline, so consulting with an attorney as soon as possible protects your rights. Waiting too long can permanently bar your ability to seek compensation, regardless of how strong your case may be.

Protecting Your Rights After a Defective Medical Device Injury

Medical device failures cause severe consequences for patients who depend on these products to manage serious health conditions. At Light & Wyatt Law Group, we understand that defective glucose monitors don’t just cause physical harm. They shatter the trust between patients and the medical devices meant to protect their health.

Our legal team has decades of experience handling product liability cases involving defective medical devices. We work with medical experts, engineers, and industry specialists to build compelling cases that hold manufacturers accountable for putting profits over patient safety. We investigate every aspect of how the defect occurred, who knew about the problem, and whether the company responded appropriately to protect consumers.

For Clearwater families dealing with injuries or loss caused by defective FreeStyle Libre sensors, we provide compassionate, comprehensive legal representation. We handle all legal complexities while you focus on recovery and health management. Our firm works on a contingency basis for personal injury cases, meaning you pay no attorney fees unless we secure compensation for your claim.

If you or a loved one was harmed by a defective FreeStyle Libre glucose monitor, contact Light & Wyatt Law Group today at 727-499-9900 for a free consultation.

Jim Magazine

James (Jim) Magazine is a Florida Board Certified Civil Trial lawyer who has spent his career helping injured victims. Jim is licensed to practice law in the State of Florida since 1990 and is also admitted to practice at the Appellate level and admitted to the United States Supreme Court.

Years of Experience: More than 30 years
Florida Registration Status: Active
Bar Admissions:
Clearwater Bar Association
West Pasco Bar Association